Transition to Natural Health Product (NPN or DIN-HIM) status for drugs formerly classified as DIN-drugs -- insurance coverage

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A note for drug plan information, sent on behalf of the Health Products and Food Branch:

To: Private and Public Drug Plan Administrators
c.c.: Canadian Pharmacists Association, NHPD Stakeholders

Subject: Transition to Natural Health Product (NPN or DIN-HIM) status for drugs formerly classified as DIN-drugs -- insurance coverage

The purpose of this letter is to share important information with you regarding the transition to Natural Health Product (NHP) status for drugs formerly classified as DIN-drugs. This information provides an update on the implementation of the Natural Health Products Regulations and the effect on products that were formerly regulated as pharmaceuticals under the Food and Drug Regulations.

Health Canada has received complaints from both consumers and the NHP industry regarding the discontinuation of insurance coverage for products that were formerly classified as DIN drugs and now classified as NHPs. Some drug plan beneficiaries have indicated that their drug plan has informed them that the change in insurance coverage for these products is due to Health Canada's reclassification of drug products to NHPs, and not a modification to the beneficiary's drug plan. This information is inaccurate and could be misleading. Given that the federal government's primary responsibility and role with respect to drugs (including NHPs) is the regulation of market access based on safety, quality and efficacy, while the provinces and territories, together with private insurers, make formulary listing decisions and set drug plan terms and conditions, we believe it is important that these differences are clearly communicated.

NHPs are included in the definition of a "drug" under the Food and Drugs Act (FDA); however, since January 1, 2004, NHPs have been regulated as a subset of drugs with a separate regulatory framework, the Natural Health Products Regulations (the NHPR). Previously, NHPs were regulated under the Food and Drug Regulations (FDR). The FDR and the NHPR provide a comparable level of regulatory oversight, with both regulatory frameworks requiring the premarket review of products for safety, quality, and efficacy, and requiring that good manufacturing practices (GMP) be met before site/establishment licences are issued (GMP requirements for NHPs are set out in Part 3 of the NHPR, while GMP requirements for drugs are set out in Division 2 of the FDR). Since January 2004 over 19,000 product licences have been issued, representing over 24,000 NHPs with varying health claims (the higher number reflects the fact that one product licence may include multiple flavours, for example). To put this number into context, a large retail outlet may carry up to 6,000 NHPs.

Health Canada would like to take this opportunity to underscore the fact that NHPs are simply a subset of drugs with a similar definition in terms of their function, the difference being that NHPs are derived from or based on naturally occurring substances instead of synthetic substances. An NHP can contain either the natural source of a substance or its synthetic duplicate. Historically, benefit plans have provided coverage for some products that were non-prescription DIN products. The transfer of these products from the FDR to the NHPR has not changed the inherent risks and benefits of these products and therefore the substantive basis for their coverage. It is hoped that this clarification will assist drug plan decision-makers in establishing product coverage based on the product itself, regardless of its designation as an NHP (identified by an NPN or DIN-HM) or a pharmaceutical or biologic drug (identified by a DIN).

Prior to the adoption of the NHPR, some products had been assessed by Health Canada and had been issued a Drug Identification Number (DIN). As of January 2004, products which had been issued a DIN and now met the definition of a NHP could get an NHP product licence (indicated by a Natural Product Number: NPN or a DIN-HM for homeopathic medicines) through the transitional-DIN product assessment process, provided that no changes to the DIN product were made. The actual DIN did not change, but the prefix that preceded the number did (e.g., DIN 01234567 now became NPN 01234567). The use of a DIN for NHPs has been phased out as of January 1, 2010. Comparable products that did not have a DIN prior to January 2004 are required to submit a new product licence application to obtain a product licence.

The Licensed Natural Health Products Database (LNHPD) contains product specific information on those NHPs that have been issued a product licence by Health Canada. The LNHPD allows public and private insurance companies, consumers, etc., to search for information on licensed NHPs according to various criteria (product name, product licence holder name, ingredient name, medicinal ingredient name, non-medicinal ingredient name, dosage form, recommended use or purpose, and NPN or DIN-HM). Health Canada continues to work on new ways to improve access to data and how it can be used. Currently, the LNHPD data extract is being developed to allow for the data within the LNHPD to be downloaded to existing databases or information systems externally, allowing for organizations to use the search criteria of their choice within their own systems. The LNHPD coupled with the Drug Product Database (DPD) will provide a complete picture of which products, whether NHPs or drugs, have received market authorization (for NHPs, a product licence) in Canada.

Compliance and enforcement action undertaken by Health Canada with respect to NHPs will continue to be guided by the Compliance Policy for Natural Health Products, which has been in force since January 2004.

Health Canada is currently working in collaboration with stakeholders to develop an updated risk-based compliance and enforcement plan.

For further information on NHPs and the NHPR, see the Natural Health Products section of the Health Canada website, or please contact us directly.

Sincerely,

Michelle Boudreau
Natural Health Products Directorate
Health Products and Food Branch
Health Canada